- Roche Holdings AG RHHBY announced new data from two global phase 3 studies, BALATON and COMINO, evaluating Vabysmo (faricimab) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO) at 24 weeks.
- The studies showed that treatment with Vabysmo resulted in early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains compared to treatment with Regeneron Pharmaceuticals Inc REGN Eyelea (aflibercept).
- Vabysmo also showed rapid and robust drying of retinal fluid from baseline, as measured by a reduction in central subfield thickness. The safety profile of Vabysmo was consistent with previous trials.
- A secondary endpoint showed that Vabysmo achieved rapid and robust drying of retinal fluid from baseline.
- Additionally, both studies showed that more Vabysmo patients had an absence of blood vessel leakage in the retina compared to aflibercept patients, as seen in a pre-specified exploratory endpoint.
- The studies are ongoing, and data from weeks 24 to 72 will assess the potential of Vabysmo to extend dosing intervals up to every four months.
- Price Action: RHHBY shares are down 1.25% at $37.89 on the last check Friday.
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